1. HYPOTHESIS FOR THE CATEGORY APPROACH (ENDPOINT LEVEL) Available data show that there is no significant variation in acute dermal toxicity between members of the category. Therefore, the general hypothesis for the category approach that xylenol isomers are characterised by similar toxicity effects and a closely related toxicokinetic behaviour applies for the endpoint "dermal absorption".

2. CATEGORY APPROACH JUSTIFICATION (ENDPOINT LEVEL )The acute dermal toxicity of 4 individual xylenol isomers was found to be low, with similar rat or rabbit LD50 values in the range from 1000 to 2400 mg/kg bw. See attached read-across justification for further information.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1 961

Report Date:

1961

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

2000 mg of the solid material per kg body weight along with 5 ml water were applied to the rabbit skin under a semi- occlusive coverage (cuff) for a 24-hour period.

GLP compliance:

no

Test material

Reference

Name:

Unnamed

Type:

Constituent

Test material form:

solid

Details on test material:

A sample from the raw material used in the Zectran process- State of aggregation:

Any other information on results incl. tables

Applicant's summary and conclusion

When the skin of rabbits was exposed to a dose level of 2000 mg 3,5-xylenol per kg body weight for 24 hours, there was no indication of absorption through the skin in acutely toxic amounts.

Executive summary:

A skin absoprtion study using the Cuff Technique was conducted according to generally acccepted scientific methods with sufficient documentation. In this test 2000 mg of 3,5-xylenol per kg body weight along with 5 ml water were applied to the skin of two rabbits under a semi-occlusive coverage (cuff) for a 24-hour period. None of the exposed rabbits died, concusively there was no indication of absorption through the skin in acutely toxic amounts.

This result can be transferred to the target test item 2,5-xylenol based on high structural similarities in the read-across category of xylenol isomers (see 'Read-across statement' in section 13.2).

Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.

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